With the FDA now rudderless with the announcement that Commissioner Marty McCully, M.D., is resigning, voices across the biopharmaceutical industry are speaking out in favor of Richard Pazdol, M.D., the FDA’s former top drug regulator, as President Donald Trump’s obvious choice to be the agency’s next commissioner.
But it remains unclear whether Pazdur wants the job, despite a vote of confidence in a letter to Trump signed by more than 100 industry leaders, including pharmaceutical and biotech CEOs, partners at venture capital firms and directors of patient advocacy groups. Last month, he told Fierce that another administration would need to occupy the White House to consider returning to the FDA.
The letter to the president says a leader like Pazdur is needed now, given that “policy instability, staff turnover, missed deadlines, and diminished scientific predictability at the FDA have created a crisis of confidence in the United States’ ability to remain a leader in biomedical advancement.”
The letter emphasized the importance of scientific credibility and independence, consistency and predictability, and reliance on FDA’s proven organizational leadership in a broader call for FDA stability.
Pazdur, who retired from the agency last December after a brief stint as director of the FDA’s Center for Drug Evaluation and Research (CDER), established a reputation for “reliability, rigor and results” during his 26-year tenure, the leaders continued.
The letter authors also highlighted Pazdur’s involvement in establishing the FDA’s Oncology Center of Excellence and praised the department he built for its ability to evaluate “each disease based on its unique biological perspective, rather than applying a one-size-fits-all framework.” Such an approach, the authors added, “is a framework that can be applied to virtually any medical condition.”
The letter concludes that even if Mr. Pazdur is not, or is not, chosen to lead the FDA, the qualities outlined here should apply to any choice the administration makes.
Given the turmoil that engulfed the FDA and other federal health agencies during the second Trump administration, it’s understandable that some industry players would want a stable and respected leader like Pazdur. Still, Pazdur has criticized the FDA’s recent practices and suggested last month that a return under President Trump is unlikely.
On the sidelines of the AACR Annual Meeting in San Diego in April, Fierce Biotech asked Pazdur if he had ever been asked to return to the FDA or was considering returning to the FDA after his retirement, and Pazdur clarified that “not under this administration,” adding that the rationale behind that stance should be “obvious.”
Fiers asked Pazdur for comment on the letter.
When Mr. Fierce spoke with Mr. Pazdul last month, the regulatory veteran, speaking at an industry partnership event during the AACR conference, was drawing attention to the past year’s “attacks on federal employees,” referring to the large-scale layoffs made at the FDA last April.
Pazdur also pointed to the agency’s apparent disdain for career employees when it comes to certain public decisions and messages, as well as its advisory committee meeting irregularly to navigate complex scientific questions and the potential pitfalls of the controversial Secretary’s National Preference Voucher (CNPV) program. Pazdur and others warn that the initiative, developed under Mr. McCulley, could unduly influence the decisions of bodies of color.
Reports first surfaced late last week that President Trump had approved the plan to fire McCurry. McCurry has come under fire from a variety of groups over FDA decisions on products such as the abortion drug mifepristone and fruit-flavored e-cigarettes, and has also faced criticism that potential political influence seeped into the regulator’s actions.
By Tuesday, Politico reported, citing unnamed administration officials, that McCurry would resign. Although official FDA documents online do not yet reflect the change, McCulley’s departure has been widely reported, and President Trump appeared to confirm the move when speaking to reporters earlier this week, calling McCulley “a great guy who is going to retire.”
Trump also appeared to confirm reports that Kyle Diamantas, the FDA’s deputy commissioner for food, would temporarily lead the agency on an acting basis, acknowledging that McCulley was “having some difficulties,” The Hill reported.
Although McCully had been the target of several factions, including pro-life groups, members of Congress, and even industry figures weary of the FDA’s leadership change and brain drain, it was Health Department Secretary Robert F. Kennedy Jr. who ultimately pushed for his removal, the report said, again citing unnamed government officials.
The alleged revelations follow recent reports that Mr. McCulley had clashed with Mr. Kennedy and HHS Chief Counsel and Medicare Commissioner Chris Klomp.
Prior to Makary’s retirement, Dr. Vinay Prasad, who had had a checkered tenure as director of the Center for Biologics Evaluation and Research, retired for the second time late last month, and was replaced by his deputy, Dr. Catherine Zalama.
